Clinical Pharmacists Role in the Management of Hypertension in Jordan

Hypertension Clinical Trial

Official title:

Clinical Pharmacists Role in the Management of Hypertension in Jordan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079494
• Other study ID #: JU8071383
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: April 6, 2010
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2009
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Background: studies have demonstrated the crucial role of clinical pharmacists as integrated part of heath care team. Not only in Jordan but also in the Middle East region, clinical pharmacy practice is not well established. This current study is the first to evaluate physicians - pharmacists' collaborative approach to uncontrolled blood pressure in Jordan and the Middle East.

Description:

Objective: this study aimed to evaluate clinical pharmacists' role in the management of uncontrolled hypertensive patients in Jordan. Design: single blinded randomized controlled clinical trial. Patients: 253 patients with uncontrolled hypertension specified as higher blood pressure readings than the recommended goals by the seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure (JNC VII) at the time of enrollment.

Interventions: patients were randomly allocated to an intervention or control group: 130 and 123 patients, respectively. Patients in both arms were followed up for 6 months. In the intervention group, patients were managed by physician-clinical pharmacist team. In the control group, patients were managed by physician(s) only and were not provided pharmaceutical care services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 88 Years

Eligibility

Inclusion Criteria:

• Patients with uncontrolled BP, receiving 0-3 antihypertensive drugs with no change in the regimen or dose within the past 3 month.

Exclusion Criteria:

• Patients with hypertensive urgency or emergency with BP more than (180/110).

• Patients with recent stroke or myocardial infraction (within past 6 months).

• Patients with Class III or IV Chronic heart Failure (CHF).

• Patients with Unstable angina.

• Patients with Serious renal or hepatic disease.

• Pregnant patients.

• Patients with Dementia or cognitive impairment.

• If the patient is unable to provide informed written consent.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• pharmaceutical care services
Patients treatment related problems and therapeutic needs or complains identified by clinical pharmacist and managed collaboratively by both pharmacist and the physician.

Locations

Country	Name	City	State
Jordan	family medicine clinic JUH	Amman

Sponsors (2)

Lead Sponsor	Collaborator
University of Jordan	Jordan Hospital

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients who achieved blood pressure goals specified by the JNC VII at each group	defined a goal to be achieved if the systolic blood pressure fell below 140 mm Hg and the diastolic blood pressure fell below 90 mm Hg. Or systolic blood pressure fell below 130 mm Hg and the diastolic blood pressure fell below 80 mm Hg if patient was diabetic.	6 month	No
Secondary	mean reductions in both systolic and diastolic blood pressure readings	mean reductions in systolic blood pressure (Systolic blood pressure at enrollment - Systolic blood pressure last follow up visit) and diastolic BP (Diastolic blood pressure at enrollment - Diastolic blood pressure last follow up visit) for both study groups	6 months	No